MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405164

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd¿ spinal needle with quincke bevel leaked medicine from the syringe connection during use.The following information was provided by the initial reporter, translated from spanish: "the anesthesiologists say that the syringe does not fit the needle and leaks when the medicine leaves.".

Event Description

It was reported that the bd¿ spinal needle with quincke bevel leaked medicine from the syringe connection during use.The following information was provided by the initial reporter, translated from spanish: "the anesthesiologists say that the syringe does not fit the needle and leaks when the medicine leaves.".

Manufacturer Narrative

The following was updated with additional information: imdrf annex a grid - medical device problem code - a1205.H6: investigation summary: no photos or physical samples that display the reported condition were provided for investigation.A device history review was performed for the reported lot 1120619 and no deviations or non conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information, we cannot identify a root cause at this time.

• Brand Name: BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859394
• MDR Text Key: 304552874
• Report Number: 2618282-2022-00079
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051648
• UDI-Public: (01)00382904051648
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405164
• Device Lot Number: 1120619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1